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The COOK® Urological Graft is for implantation to reinforce soft tissues where weakness exists in the urological anatomy, including temporary wound or solid organ support in the kidney. The Urological Graft is supplied sterile and intended for one-time use.

The COOK® Urological Graft is a bioabsorbable, extracellular collagen matrix that is identical to the predicates SURGIS Mesh (K980431) and SURGISIS® Sling (K992159), also manufactured by COOK Biotech Incorporated, and to Vicryl Mesh bag (K051701), manufactured by Ethicon. The device is manufactured from porcine small intestinal submucosa (SIS), packaged in a lyophilized (dried) state and supplied sterile in a sealed double pouch system.

The provided text describes a 510(k) submission for the COOK® Urological Graft and does not contain information about acceptance criteria or a study proving the device meets said criteria in the way typically found for AI/ML medical devices (e.g., performance metrics like sensitivity, specificity, AUC).

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the cornerstone of the 510(k) pathway. The study mentioned refers to the type of testing performed to prove this equivalence, rather than a performance study against specific acceptance criteria for a novel AI/ML algorithm.

Therefore, the requested information cannot be fully provided as the context is different from what the prompt anticipates for AI/ML device studies.

However, I can extract what is relevant to the prompt, even if it's not a direct match to the AI/ML framework:

1. A table of acceptance criteria and the reported device performance

This document does not define specific "acceptance criteria" in terms of quantitative performance metrics (like sensitivity, specificity, or AUC) that an AI/ML model would need to meet. For a 510(k) submission of a traditional medical device like the COOK® Urological Graft, the primary "acceptance criterion" is substantial equivalence to predicate devices.

Reported Device Performance (as it relates to substantial equivalence):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "bench, animal, biocompatibility and clinical testing" to establish equivalence. However, it does not provide details on:

• The specific sample sizes used for these tests.
• The data provenance (e.g., country of origin, retrospective/prospective nature) for any clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is a physical surgical graft, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth on a test set. The "ground truth" for demonstrating equivalence would be derived from the performance and characteristics of the predicate devices and the results of the specific engineering, animal, and clinical tests performed on the COOK® Urological Graft itself.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for a physical medical device submission demonstrating substantial equivalence. Adjudication methods are typically relevant for human interpretation or AI/ML output assessment where discrepancies might arise.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a surgical graft, not an AI-assisted diagnostic tool, so MRMC studies or human reader improvement with AI are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a physical surgical graft, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For this type of device, the "ground truth" for demonstrating substantial equivalence would be based on:

• Material properties data: Bench testing results on tensile strength, bioabsorption rates, pore size, etc.
• Biocompatibility data: Standardized tests for cytotoxicity, sensitization, irritation, etc., according to ISO standards.
• Animal study data: In vivo performance in terms of tissue integration, host response, strength, and degradation over time.
• Clinical safety and performance data (if collected): Surgical outcomes, adverse event rates, and efficacy in repairing or reinforcing tissues, compared to predicates. This data would be against established clinical endpoints and observations from healthcare professionals and patient outcomes.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that uses a "training set."

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device, so there is no training set or ground truth in that context.

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The AMS collagen dermal matrix is intended for use in the treatment of hernias where the The AMS collagen ochharmania in to implantation to reinforce soft tissues where weakness Connective lissoc has ruptured of for implanations of this includes but is not limited to the following procedures: pubourethral support including urethral slings, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, sacral colposuspension and reinforcement in the repair of Peyronie's disease. By providing pubourethral support, the AMS collagen dermal matrix may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

The Bioarc SP Sling Kit with Pre-connected Collagen Dermal Matrix and Bioarc TO Sublascial Hammock with Pre-connected Collagen Dermal Matrix are intended for the placement of a pubourethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The AMS Perigee System with Pre-Connected Collagen Dermal Matrix is intended for the placement of graft material in the anterior vaginal wall via the obturator foramen for the treatment of anterior wall prolapse.

The AMS Apogee System with Pre-Connected Collagen Dermal Matrix is intended for use in vaginal vault suspension to treat pelvic organ prolapse.

The AMS collagen dermal matrix is decellularized porcine dermis that is lyophilized and terminally sterilized. The product is available in a range of sizes.

The Bioarc SP Sling Kit with Pre-connected Collagen Dermal Matrix and Bioarc TO Sublascial Hammock with Pre-connected Collagen Dermal Matrix consist of needles and connectors used to pass a polypropylene mesh preconnected to porcine dermis for use as a urethral sling.

The Perigee System with Pre-Connected Collagen Dermal Matrix consists of needles and connectors used to pass a polypropylene mesh preconnected to porcine dermis in support of the anterior vaginal wall.

The AMS Apoqee System with Pre-Connected Collagen Dermal Matrix consists of needles and connectors used to pass a polypropylene mesh preconnected to porcine dermis in support of the vaginal vault.

The provided text describes a 510(k) summary for the AMS Collagen Dermal Matrix. This is a premarket notification for a medical device seeking clearance based on substantial equivalence to predicate devices, not a study proving device meeting acceptance criteria as would typically be conducted for and reported for an AI/ML device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission. The submission focuses on demonstrating equivalence to existing surgical mesh products.

However, I can extract information related to the device's intended use and the general claim of meeting "requirements" for this type of device.

Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation of "Acceptance Criteria" for a 510(k) of this nature:

For a 510(k) submission like this one (for a traditional medical device prior to the widespread use of AI/ML), "acceptance criteria" are not typically quantitative thresholds on metrics like accuracy or sensitivity. Instead, the primary acceptance criterion is substantial equivalence to a legally marketed predicate device. This is demonstrated by showing:

• Similar intended use.
• Similar technological characteristics (materials, design).
• Evidence that any differences in technological characteristics do not raise new questions of safety or effectiveness.

The "testing" mentioned typically involves biocompatibility, mechanical properties, sterilization validation, and often animal studies, which are compared to known properties of the predicate devices or established standards. The text does not provide granular details of these tests or their specific outcome values.

2. Sample size used for the test set and the data provenance:

• Not Applicable. This is a 510(k) for a surgical mesh, not a data-driven AI/ML device. There is no "test set" in the context of an algorithm's performance on data. The "testing" refers to benchtop, possibly animal, and material property tests to establish equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. See point 2.

4. Adjudication method for the test set:

• Not Applicable. See point 2.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is not an AI/ML device, and no MRMC study was mentioned or would be relevant for this type of device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is not an AI/ML device.

7. The type of ground truth used:

• Not Applicable. For a surgical mesh, "ground truth" relates to the performance and safety characteristics established through laboratory testing (e.g., tensile strength, biocompatibility, porosity) and potentially animal studies, compared against the known characteristics of predicate devices and general scientific principles for medical device design. It's not "ground truth" in the sense of expert-annotated data for an AI/ML model.

8. The sample size for the training set:

• Not Applicable. This is a traditional medical device, not an AI/ML device. There is no "training set" in this context.

9. How the ground truth for the training set was established:

• Not Applicable. See point 8.

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The PelviLace™ Transobturator BioUrethral Support System is intended for use as a soft tissue patch to reinforce soft tissue membranes. It is specifically indicated for use in the surgical repair of tissue resulting from damaged or ruptured soft tissue and for the inhibition of stress urinary incontinence in women resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Bard® PelviLace™ TO BioUrethral Support System consists of the PelviLace Pelvicol implant and introducers. The introducers are used to place the implant which provides a natural backboard for the urethra during abdominal pressure increases.

This document is a 510(k) summary for the PelviLace™ TO BioUrethral Support System, a suburethral sling device. It details the device's description, intended use, and technological characteristics compared to predicate devices. However, this document does not contain information related to specific acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked.

Therefore, I cannot provide the requested information from the provided text. The document primarily focuses on establishing substantial equivalence to predicate devices for regulatory purposes.

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The Bard® InnerLace™ BioUrethral Support System is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for use as a pubourethral sling for the treatment of stress urinary incontinence in women resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Bard® InnerLace" BioUrethral Support System consists of a Bard InnerLace™ System Pelvicol® implant and an introducer device to facilitate quick and simple placement of the implant. The Bard® InnerLace™ System Pelvicol® Implant is positioned suburethrally to provide a natural backboard for the urethra during abdominal pressure increases.

The introducer allows a choice of either suprapubic or retropubic implantation techniques depending on physician preference. The introducer set includes a removable handle, two introducer needles, and four snap-on tissue connectors.

The provided document describes a 510(k) summary for the Bard® InnerLace™ BioUrethral Support System. This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the way a new device's efficacy or safety study would.

Therefore, an acceptance criteria table and a detailed study proving the device meets those criteria, as typically understood for AI/ML device evaluations, are not present in this document.

Here's an analysis of the provided information in the context of the requested sections:

1. A table of acceptance criteria and the reported device performance:

   • Not Applicable. This document does not present specific quantitative acceptance criteria or performance metrics for the device. The 510(k) submission aims to demonstrate substantial equivalence, not to meet pre-defined performance thresholds through a new clinical or technical study as would be seen for a novel device. The "Performance Data Summary" explicitly states: "The Bard® InnerLace™ BioUrethral Support System is substantially equivalent to the predicate devices with regard to biocompatibility, materials and product characterization. The modified design of the Bard® InnerLace™ System Pelvicol® Implant does not raise any new types of safety or efficacy issues." This indicates a comparison to an existing device, not a new performance study against specific criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not Applicable. The document does not describe a test set or data provenance for a study. The information focuses on the device description and its intended use, asserting equivalence to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not Applicable. As no specific performance study with a test set is described, there's no mention of experts establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable. No test set or associated adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not Applicable. This device is a surgical mesh, not an AI/ML-driven diagnostic or imaging device. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This is a physical medical device (surgical mesh), not an algorithm. Standalone algorithm performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not Applicable. No ground truth is established in the context of a new performance study. The substantial equivalence relies on the established safety and efficacy of the predicate device.

8. The sample size for the training set:

   • Not Applicable. This device is a surgical mesh, not an AI/ML system requiring a training set.

9. How the ground truth for the training set was established:

   • Not Applicable. Not an AI/ML system; no training set or ground truth for training is relevant.

In summary, the provided 510(k) submission for the Bard® InnerLace™ BioUrethral Support System is a regulatory document focused on demonstrating substantial equivalence to a legally marketed predicate device (Permacol® Acellular Collagen Matrix) based on manufacturing processes, materials, and product characterization, rather than presenting a performance study with specific acceptance criteria and test results for a novel device or AI/ML system.

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For use in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female urinary incontinence resulting from urethral hypermobility or sphincter deficiency.

(Trade name) is a sterile, processed and treated porcine skin, which is intended for use in the reconstruction of soft tissue deficiencies.

The provided text does not contain the acceptance criteria or information about a study proving the device meets acceptance criteria.

The document is a 510(k) summary for a surgical mesh, focusing on its substantial equivalence to predicate devices. It discusses:

• Device Name: Brennen Biosynthetic Surgical Mesh Matrix
• Indication for Use: Treatment of hernias and as a sling material for female urinary incontinence.
• Device Description: Sterile, processed, and treated porcine skin.
• Technological Characteristics and Performance: States that "The technological characteristics are the same or equivalent to the predicate device. Testing and review of the literature has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device."

Missing Information:
The document does not provide any specific details regarding acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for either training or test sets. It merely asserts that "testing and review of the literature" was done to demonstrate substantial equivalence, but offers no specifics about these tests.

Therefore, I cannot populate the table or answer the specific questions based on the provided text.

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The STRATASISTM Sling Kit is a sterile, single-use device intended to be used as a pubourethral sling indicated for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The STRATASISTM Sling Kit is composed of a strip of SIS material with TEVDEK® suture attached to each end. Two stainless steel ligature carriers are also included.

The provided text describes a 510(k) premarket notification for the STRATASIS™ Sling Kit. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit acceptance criteria with quantitative performance metrics. Therefore, the information typically requested in your prompt (e.g., specific performance criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader studies, ground truth types) is not present in the provided document, as it is generally not required for a 510(k) summary focused on substantial equivalence based on materials, construction, and intended use.

However, I can extract information related to the "tests" performed and the "conclusions drawn," which are the closest equivalents to demonstrating criteria satisfaction in this context.

Here's a breakdown of what can be extracted and an explanation of why other requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The 510(k) summary only states that the device "met the requirements of all tests" for biocompatibility, disinfection, and performance characteristics. It does not provide specific quantitative acceptance thresholds or detailed performance outcomes for these tests. The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. 510(k) summaries for devices like surgical meshes typically do not include clinical study details of this nature unless a de novo classification or complex performance data is required. The "tests" mentioned are likely bench tests and material characterization, not patient-based test sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided as there is no mention of a clinical test set or ground truth established by experts. The "tests" refer to laboratory and material evaluations.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided as there is no mention of a clinical test set or adjudication process.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/provided. The device is a surgical sling, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable/provided. The device is a surgical sling, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided. For a surgical mesh, ground truth is typically assessed through detailed material testing, biocompatibility studies, and in some cases, animal model or clinical trial outcomes to demonstrate safety and efficacy. However, for a 510(k) of this nature, detailed outcomes data acting as "ground truth" for a performance study is usually not the primary focus, especially when substantial equivalence to well-established predicates is the claim.

8. The sample size for the training set

This information is not applicable/provided. The device is a physical surgical implant, not an AI model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable/provided. The device is a physical surgical implant, not an AI model.

In summary: The provided document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" of the STRATASISM Sling Kit to existing predicate devices based on its intended use, materials, and physical construction. It confirms that the device underwent and met requirements for biocompatibility, disinfection, and performance characteristics through un-detailed "tests." It does not contain the kind of detailed performance data, clinical study specifics, or AI-related information requested, as that is not typically part of a 510(k) premarket notification for a device of this type in 2002.

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For use in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female urinary incontinence resulting from urethral hypermobility or sphincter deficiency.

[Trade name] is a sterile, processed and treated porcine skin, which is intended for use in the reconstruction of soft tissue deficiencies.

This document is a 510(k) summary for a surgical mesh. It does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The information provided describes the device, its intended use, and states that its technological characteristics and performance are "the same as or equivalent to the predicate device." It also mentions that "Biocompatibility and bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device." However, no specific details about these tests, the acceptance criteria used, or the results are provided.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance study results
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document is a high-level summary for regulatory submission, not a detailed study report.

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The Surgisis® Sling is intended for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy including but not limited to the following procedures: transvaginal repair of stress urinary incontinence, such as pubourethral support and bladder support, and transabdominal repair of apical vaginal prolapse, colon and rectal prolapse, and sacrocolposuspension. By providing pubourethral support, the sling may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency. The device is supplied sterile and is intended for one-time use.

The Surgisis® Sling is supplied in sheet form in sizes ranging from 20 cm2 to 140 cm2. The device is packaged in sterile, sealed double pouches.

This document is a 510(k) Summary for the Surgisis® Sling, a surgical mesh device. It does not provide information about acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like sensitivity, specificity, or any other quantitative measures typically associated with AI/ML device evaluations.

The document focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use: The Surgisis® Sling has the same intended use as its predicates (K980431, K954665, K980483, K963226).
• Technological Characteristics: The device is stated to have the same technological characteristics as the predicate devices.
• Testing for Biocompatibility, Integrity, and Performance: The document states that the Surgisis® Sling "passed the requirements of all tests" in these areas. However, it does not specify what these requirements or performance metrics were, nor does it provide the results of these tests in a detailed manner.

Therefore, I cannot provide the requested information for an AI/ML device as this document pertains to a traditional medical device (surgical mesh) where the evaluation criteria are different. The concept of "acceptance criteria" in this context refers to meeting the standards of biocompatibility, integrity, and equivalent performance to existing devices, rather than statistical performance metrics for an AI algorithm.

Summary of what can be extracted, and what cannot:

1. Table of acceptance criteria and reported device performance:

   • Acceptance Criteria (Implied): Biocompatibility, Integrity, Performance (in relation to predicate devices).
   • Reported Device Performance: "The Surgisis® Sling passed the requirements of all tests." No specific quantitative performance metrics are provided.

2. Sample size used for the test set and data provenance:

   • Not applicable/Not provided. The document refers to "tests" on the device itself (e.g., material properties), not a "test set" of patient data for an algorithm.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

   • Not applicable/Not provided. Ground truth in the context of an AI/ML device would involve annotations by experts on medical data. This document doesn't involve that.

4. Adjudication method:

   • Not applicable/Not provided.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:

   • Not applicable/Not performed. This is for evaluating AI assistance to human readers.

6. Standalone (algorithm only) performance:

   • Not applicable/Not performed. This device is not an algorithm.

7. Type of ground truth used:

   • Not applicable in the AI/ML sense. The "ground truth" for this device would be established engineering and biological standards for surgical mesh materials.

8. Sample size for the training set:

   • Not applicable/Not provided. This document describes a physical medical device, not an AI algorithm.

9. How the ground truth for the training set was established:

   • Not applicable.

In conclusion, the provided document describes a premarket notification (510(k)) for a conventional surgical mesh, focusing on substantial equivalence to existing devices. It does not contain the type of information related to acceptance criteria, test sets, ground truth, or study designs that would be relevant for an AI/ML medical device.

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The Brennen Biosynthetic Surgical Mesh is indicated in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female winary incontinence resulting from urethral hypermobility or sphincter deficiency.

Brennen Biosynthetic Surgical Mesh Matrix

I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for a surgical mesh, focusing on regulatory aspects, indications for use, and legal compliance. It does not include details about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.

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